Proposal for a Council Decision authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize Bt11xGA21 (SYN-BTØ11-1xMON-ØØØ21-9) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (Only the French text is authentic) (Text with EEA relevance)
Date: 2010-06-04
Institutions: European Commission
Subjects: food safety, foodstuffs legislation, genetically modified organism, health risk, labelling, maize, market approval

EN 

EN 

   EN 

 
 
EUROPEAN COMMISSION 

Brussels, 4.6.2010 
COM(2010)294 final 

2010/0157 (NLE) 

Proposal for a 

COUNCIL DECISION 

authorising the placing on the market of products containing, consisting of, or produced 
from genetically modified maize Bt11xGA21 (SYN-BTØ11-1xMON-ØØØ21-9) pursuant 
to Regulation (EC) No 1829/2003 of the European Parliament and of the Council 

(Only the French text is authentic) 
(Text with EEA relevance) 

EN 

   EN 

 
 
 
EXPLANATORY MEMORANDUM 

The attached proposal for a Council Decision concerns food and feed containing, consisting 
of or produced from genetically modified maize Bt11xGA21, for which a request for placing 
on  the  market  was  submitted  by  Syngenta  Seeds  S.A.S.  to  the  competent  authority  of  the 
United  Kingdom  on  31  October  2007,  under  Regulation  (EC)  No  1829/2003  on  genetically 
modified food and feed.  

The attached proposal also concerns the placing on the market of products other than food and 
feed containing or consisting of Bt11xGA21 maize for the same uses as any other maize with 
the exception of cultivation. 

On  22  September  2009,  the  European  Food  Safety  Authority  gave  a  favourable  opinion  in 
accordance  with  Articles  6  and  18  of  Regulation  (EC)  No  1829/2003.  It  considered  that 
Bt11xGA21  maize  is  as  safe  as  its  non-genetically  modified  counterpart  with  respect  to 
potential effects on human and animal health or the environment. Therefore it concluded that 
it  is  unlikely  that  the  placing  on  the  market  of  the  products  containing,  consisting  of,  or 
produced  from  Bt11xGA21  maize  as  described  in  the  application  will  have  any  adverse 
effects on human or animal health or the environment in the context of their intended uses. 

Against this background, a draft Commission Decision authorising the placing on the Union 
market  of  products  containing,  consisting  of  or  produced  from  genetically  modified 
Bt11xGA21 maize was submitted to the Standing Committee on the Food Chain and Animal 
Health, on 19 April 2010, for vote. The Committee delivered no opinion: 11 Member States 
(164  votes)  voted  in  favour,  10  Member  States  (87  votes)  voted  against,  3 Member  States 
(46 votes) abstained and 3 Member States (48 votes) were not represented. 

Consequently, pursuant to Article 35, paragraph 2 of Regulation (EC) No 1829/2003 and in 
accordance  with  Article  5  of  Council  Decision  1999/468/EC  modified  by  Council  Decision 
2006/512/EC, the Commission is required to submit to the Council a proposal relating to the 
measures to be taken, the Council having three months in which to act by a qualified majority, 
and inform the Parliament. 

EN 

2 

   EN 

 
2010/0157 (NLE) 

Proposal for a  

COUNCIL DECISION 

authorising the placing on the market of products containing, consisting of, or produced 
from genetically modified maize Bt11xGA21 (SYN-BTØ11-1xMON-ØØØ21-9) pursuant 
to Regulation (EC) No 1829/2003 of the European Parliament and of the Council 

(Only the French text is authentic) 
(Text with EEA relevance) 

THE COUNCIL OF THE EUROPEAN UNION, 

Having regard to the Treaty on the Functioning of the European Union, 

Having  regard  to  Regulation  (EC)  No  1829/2003  of  the  European  Parliament  and  of  the 
Council  of  22  September  2003  on  genetically  modified  food  and  feed1,  and  in  particular 
Articles 7(3) and 19(3) thereof, 

Having regard to the proposal of the European Commission, 

Whereas: 

(1) 

(2) 

On  31  October  2007,  Syngenta  Seeds  S.A.S.  on  behalf  of  Syngenta  Crop  Protection 
AG  submitted  to  the  competent  authority  of  the  United  Kingdom  an  application,  in 
accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003, for the placing 
on  the  market  of  foods,  food  ingredients,  and  feed  containing,  consisting  of,  or 
produced from Bt11xGA21 maize ('the application'). 

The application also covers the placing on the market of products other than food and 
feed  containing  or  consisting  of  Bt11xGA21  maize  for  the  same  uses  as  any  other 
maize  with  the  exception  of  cultivation.  Therefore,  in  accordance  with  Articles  5(5) 
and  17(5)  of  Regulation  (EC)  No  1829/2003,  it  includes  the  data  and  information 
required by Annexes III and IV to Directive 2001/18/EC of the European Parliament 
and of the Council of 12 March 2001 on the deliberate release into the environment of 
genetically  modified  organisms  and  repealing  Council  Directive  90/220/EEC2  and 
information and conclusions about the risk assessment carried out in accordance with 
the  principles  set  out  in  Annex  II  to  Directive  2001/18/EC.  It  also  includes  a 
monitoring  plan  for  environmental  effects  conforming  with  Annex  VII  to  Directive 
2001/18/EC. 

(3) 

On  22  September  2009,  the  European  Food  Safety  Authority  ('EFSA’)  gave  a 
favourable  opinion  in  accordance  with  Articles  6  and  18  of  Regulation  (EC)  No 

1 
2 

OJ L 268, 18.10.2003, p. 1. 
OJ L 106, 17.4.2001, p. 1.  

EN 

3 

   EN 

 
                                                 
(4) 

(5) 

(6) 

(7) 

1829/2003.  It  considered  that  maize  Bt11xGA21  is  as  safe  as  its  non-genetically 
modified counterpart with respect to potential effects on human and animal health or 
the  environment.  Therefore  it  concluded  that  it  is  unlikely  that  the  placing  on  the 
market of the products containing, consisting of, or produced from Bt11xGA21 maize 
as described in the application ('the products') will have any adverse effects on human 
or  animal  health  or  the  environment  in  the  context  of  their  intended  uses3.  In  its 
opinion,  EFSA  considered  all  the  specific  questions  and  concerns  raised  by  the 
Member States in the context of the consultation of the national competent authorities 
as provided for by Articles 6(4) and 18(4) of that Regulation. 

In  its  opinion,  EFSA  also  concluded  that  the  environmental  monitoring  plan, 
consisting of a general surveillance plan, submitted by the applicant is in line with the 
intended use of the products. 

Taking  into  account  those  considerations,  authorisation  should  be  granted  for  the 
products. 

A unique identifier should be assigned to each GMO as provided for in Commission 
Regulation  (EC)  No  65/2004  of  14  January  2004  establishing  a  system  for  the 
development and assignment of unique identifiers for genetically modified organisms4. 

On the basis of the EFSA opinion, no specific labelling requirements other than those 
provided for in Articles 13(1) and 25(2) of Regulation (EC) No 1829/2003, appear to 
be  necessary  for  foods,  food  ingredients  and  feed  containing,  consisting  of,  or 
produced from Bt11xGA21 maize. However, in order to ensure the use of the products 
within  the  limits  of  the  authorisation  provided  for  by  this  Decision,  the  labelling  of 
feed  containing  or  consisting  of  the  GMO  and  products  other  than  food  and  feed 
containing  or  consisting  of  the  GMO  for  which  authorisation  is  requested  should  be 
complemented by a clear indication that the products in question must not be used for 
cultivation.  The  authorisation  holder  should  submit  annual  reports  on 
the 
implementation  and  the  results  of  the  activities  set  out  in  the  monitoring  plan  for 
environmental  effects.  Those  results  should  be  presented  in  accordance  with 
Commission  Decision  2009/770/EC  of  13  October  2009  establishing  standard 
reporting  formats  for  presenting  the  monitoring  results  of  the  deliberate  release  into 
the environment of genetically modified organisms, as or in products, for the purpose 
of  placing  on  the  market,  pursuant  to  Directive  2001/18/EC  of  the  European 
Parliament and of the Council5. 

(8) 

Similarly, the EFSA opinion does not justify the imposition of specific conditions or 
restrictions for the placing on the market and/or specific conditions or restrictions for 
the use and handling, including post-market monitoring requirements for the use of the 
the  protection  of  particular 
food  and  feed,  or  of  specific  conditions  for 
ecosystems/environment  and/or  geographical  areas,  as  provided  for  in  point  (e)  of 
Articles 6(5) and 18(5) of Regulation (EC) No 1829/2003.  

3 
4 
5 

http://registerofquestions.efsa.europa.eu/roqFrontend/questionLoader?question=EFSA-Q-2006-020 
OJ L 10, 16.1.2004, p. 5. 
OJ L 275, 21.10.2009, p. 9. 

EN 

4 

   EN 

 
                                                 
(9) 

All relevant information on the authorisation of the products should be entered in the 
Community  register  of  genetically  modified  food  and  feed,  as  provided  for  in 
Regulation (EC) No 1829/2003.  

(10)  Article 4(6) of Regulation (EC) No 1830/2003 of the European Parliament and of the 
Council of 22 September 2003 concerning the traceability and labelling of genetically 
modified  organisms  and  the  traceability  of  food  and  feed  products  produced  from 
genetically  modified  organisms  and  amending  Directive  2001/18/EC6,  lays  down 
labelling requirements for products consisting of, or containing GMOs. 

(11)  This Decision is to be notified through the Biosafety Clearing-House to the Parties to 
the  Cartagena  Protocol  on  Biosafety  to  the  Convention  on  Biological  Diversity, 
pursuant to Article 9(1) and Article 15(2)(c) of Regulation (EC) No 1946/2003 of the 
European Parliament and of the Council of 15 July 2003 on transboundary movements 
of genetically modified organisms7. 

(12)  The applicant has been consulted on the measures provided for in this Decision. 

(13)  The Standing Committee on the Food Chain and Animal Health has not delivered an 

opinion within the time-limit laid down by its Chairman, 

HAS ADOPTED THIS DECISION: 

Article 1 
Genetically modified organism and unique identifier 

Genetically modified maize (Zea mays L.) Bt11xGA21 as specified in point (b) of the Annex 
to  this  Decision,  is  assigned  the  unique  identifier  SYN-BTØ11-1xMON-ØØØ21-9,  as 
provided for in Regulation (EC) No 65/2004. 

Article 2 
Authorisation  

The  following  products  are  authorised  for  the  purposes  of  Articles  4(2)  and  16(2)  of 
Regulation (EC) No 1829/2003 in accordance with the conditions set out in this Decision: 

(a) 

(b) 

(c) 

foods and food ingredients containing, consisting of, or produced from SYN-BTØ11-
1xMON-ØØØ21-9 maize;  

feed  containing,  consisting  of,  or  produced  from  SYN-BTØ11-1xMON-ØØØ21-9 
maize;  

products other than food and feed containing or consisting of SYN-BTØ11-1xMON-
ØØØ21-9  maize  for  the  same  uses  as  any  other  maize  with  the  exception  of 
cultivation. 

6 
7 

OJ L 268, 18.10.2003, p. 24. 
OJ L 287, 5.11.2003, p. 1. 

EN 

5 

   EN 

 
                                                 
Article 3 
Labelling 

1. 

2. 

1. 

2. 

For the purposes of the labelling requirements laid down in Articles 13(1) and 25(2) 
of  Regulation  (EC)  No  1829/2003  and  in  Article  4(6)  of  Regulation  (EC)  No 
1830/2003, the ’name of the organism’ shall be ’maize’. 

The  words  'not  for  cultivation'  shall  appear  on  the  label  of  and  in  documents 
accompanying products containing or consisting of SYN-BTØ11-1xMON-ØØØ21-9 
maize referred to in Article 2(b) and (c). 

Article 4 
Monitoring for environmental effects 

The  authorisation  holder  shall  ensure  that  the  monitoring  plan  for  environmental 
effects, as set out in point (h) of the Annex, is put in place and implemented. 

The  authorisation  holder  shall  submit  to  the  Commission  annual  reports  on  the 
implementation  and  the  results  of  the  activities  set  out  in  the  monitoring  plan  in 
accordance with Decision 2009/770/EC. 

Article 5 
Community register 

The  information  set  out  in  the  Annex  to  this  Decision  shall  be  entered  in  the  Community 
register  of  genetically  modified  food  and  feed,  as  provided  for  in  Article  28  of  Regulation 
(EC) No 1829/2003. 

Article 6 
Authorisation holder 

The authorisation holder shall be Syngenta Seeds S.A.S., France, representing Syngenta Crop 
Protection AG, Switzerland. 

This Decision shall apply for a period of 10 years from the date of its notification. 

Article 7 
Validity 

EN 

6 

   EN 

 
Article 8 
Addressee 

This Decision is addressed to Syngenta Seeds S.A.S., Chemin de l'Hobit 12, BP 27 – F-31790 
Saint-Sauveur - France. 

Done at Brussels, 

For the Council 
The President 

EN 

7 

   EN 

 
 
 
ANNEX 

(a) 

Applicant and Authorisation holder: 

Name: 

Syngenta Seeds S.A.S. 

Address: 

Chemin de l'Hobit 12, BP 27 – F-31790 Saint-Sauveur – France 

On behalf of Syngenta Crop Protection AG - Schwarzwaldallee 215 - CH 4058 Basle 
- Switzerland 

(b) 

Designation and specification of the products:  

(1)  Foods and food ingredients containing, consisting of, or produced from SYN-

BTØ11-1xMON-ØØØ21-9 maize; 

(2)  Feed  containing,  consisting  of,  or  produced  from  SYN-BTØ11-1xMON-

ØØØ21-9 maize; 

(3)  Products  other  than  food  and  feed  containing  or  consisting  of  SYN-BTØ11-
1xMON-ØØØ21-9  maize  for  the  same  uses  as  any  other  maize  with  the 
exception of cultivation. 

The genetically modified SYN-BTØ11-1xMON-ØØØ21-9 maize, as described in the 
application,  is  produced  by  crosses  between  maize  containing  SYN-BTØ11-1  and 
MON-ØØØ21-9 events and expresses the Cry1Ab protein which confers protection 
against  certain  lepidopteran  pests,  the  mEPSPS  protein  which  confers  tolerance  to 
glyphosate  herbicides  and  a  PAT  protein  which  confers  tolerance  to  glufosinate-
ammonium herbicides. 

(c) 

Labelling: 

(1)  For  the  purposes  of  the  specific  labelling  requirements  laid  down  in  Articles 
13(1)  and  25(2)  of  Regulation  (EC)  No  1829/2003,  and  in  Article  4(6)  of 
Regulation (EC) No 1830/2003, the ’name of the organism’ shall be ’maize’; 

(2)  The  words  'not  for  cultivation'  shall  appear  on  the  label  of  and  in  documents 
accompanying  products  containing  or  consisting  of  SYN-BTØ11-1xMON-
ØØØ21-9 maize referred to in Article 2(b) and (c) of this Decision. 

(d) 

Method for detection: 

– 

– 

– 

Event  specific  real-time  quantitative  PCR  based  methods  for  genetically 
modified maize SYN-BTØ11-1 and MON-ØØØ21-9 maize validated on SYN-
BTØ11-1xMON-ØØØ21-9 maize; 

Validated on seeds by the Community Reference Laboratory established under 
Regulation 
http://gmo-
(EC) 
crl.jrc.ec.europa.eu/statusofdoss.htm; 

1829/2003, 

published 

No 

at 

Reference Material: ERM®-BF412 (for SYN-BTØ11-1) accessible via the 
Joint Research Centre (JRC) of the European Commission, Institute for 

EN 

8 

   EN 

 
Reference Materials and Measurements (IRMM) at 
https://irmm.jrc.ec.europa.eu/rmcatalogue and AOCS 0407 (for MON-ØØØ21-
9 ) accessible via the American Oil Chemists Society at 
http://www.aocs.org/tech/crm 

(e) 

Unique identifier: 

SYN-BTØ11-1xMON-ØØØ21-9  

(f) 

Information required under Annex II to the Cartagena Protocol on Biosafety to 
the Convention on Biological Diversity: 

Biosafety Clearing-House, Record ID: see [to be completed when notified]. 

(g) 

Conditions or restrictions on the placing on the market, use or handling of the 
products: 

Not required. 

(h) 

Monitoring plan 

Monitoring plan for environmental effects conforming with Annex VII to Directive 
2001/18/EC. 

[Link: plan published on the internet] 

(i) 

Post  market  monitoring  requirements  for  the  use  of  the  food  for  human 
consumption 

Not required. 

Note: links to relevant documents may need to be modified over the time. Those modifications 
will be made available to the public via the updating of the Community register of genetically 
modified food and feed. 

EN 

9 

   EN